Coleman, Rob, Brown, Janet, Rathbone, Emma, Flanagan, Louise, Reid, Amber, Kendall, Jessica, Howell, Sacha, Twelves, Chris, Palmieri, Carlo 
ORCID: 0000-0001-9496-2718, Anand, Anjana et al (show 2 more authors)
(2020)
CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases (CARBON): study protocol for a phase IB/IIA randomised controlled trial.
TRIALS, 21 (1).
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CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases (CARBON) study protocol for a phase IB.pdf - Published version Download (1MB) | Preview |
Abstract
<h4>Background</h4>A substantial proportion of breast cancer patients develop metastatic disease, with over 450,000 deaths globally per year. Bone is the most common first site of metastatic disease accounting for 40% of all first recurrence and 70% of patients with advanced disease develop skeletal involvement. Treatment of bone metastases currently focusses on symptom relief and prevention and treatment of skeletal complications. However, there remains a need for further treatment options for patients with bone metastases. Combining systemic therapy with a bone-targeted agent, such as radium-223, may provide an effective treatment with minimal additional side effects.<h4>Methods/design</h4>CARBON is a UK-based, open-label, multi-centre study which comprises an initial safety phase to establish the feasibility and safety of combining radium-223 given on a 6-weekly schedule in combination with orally administered capecitabine followed by a randomised extension phase to further characterise the safety profile and provide preliminary estimation of efficacy.<h4>Discussion</h4>The CARBON study is important as the results will be the first to assess radium-223 with chemotherapy in advanced breast cancer. If the results find acceptable rates of toxicity with a decrease in bone turnover markers, further work will be necessary in a phase II/III setting to assess the efficacy and clinical benefit.<h4>Trial registration</h4>ISRCTN, ISRCTN92755158, Registered on 17 February 2016.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Radium-223, Capecitabine, Bone metastases, Bone turnover markers, Breast cancer |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 15 Feb 2021 08:36 |
| Last Modified: | 30 Jan 2024 10:49 |
| DOI: | 10.1186/s13063-019-3643-6 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3115611 |
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